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Friday, November 22, 2013

Researchers Recruiting 5,000 First-Degree Relatives of People with MS for Genetic/Environmental Research Study

Researchers from the Harvard Medical School, Brigham and Women’s Hospital, and Partners Multiple Sclerosis Center, in collaboration with the National Institute of Neurological Disorders and Stroke (a branch of the National Institute of Health, NIH), are recruiting 5,000 subjects who have at least one first-degree relative with a diagnosis of MS. The goal of the study is to identify the genetic, environmental and immune profiles that may increase a person’s risk of developing MS. A first-degree relative could be a parent, sibling, or child of a person with MS, and the study is limited to those between 18 and 50 years of age. The GEMS (Genes and Environment in MS) study is led by primary investigator Philip De Jager, MD, PhD, a Harry Weaver Neuroscience Scholar of the National MS Society. The study is privately funded. Daniel Reich, MD, PhD, is the site principal investigator at NIH.

Background: An individual's risk of developing MS increases several-fold if a close family member has MS. There is currently no way to predict which family members will develop MS. Genetic, environmental and immunologic studies to date have identified key markers that are associated with the risk of MS. The GEMS Study is gathering genetic material (DNA) and environmental exposure history from participant as well as blood samples and brain magnetic resonance imaging (MRI) as an option. Investigators are testing the performance of a new method of identifying persons at risk for MS. Identifying high-risk individuals will influence the design of effective preventive strategies for MS.

The Study: Investigators are recruiting 5,000 first-degree relatives of MS patients. A first-degree relative could be a parent, sibling, or child between 18 and 50 years of age. The first-degree relative may or may not have an existing diagnosis of MS, but must have the ability to provide consent and be willing to participate in the study.

All 5,000 participants are being asked to donate a saliva sample for DNA analysis and complete a questionnaire about neurologic history, family history and potential environmental exposures. Based on answers to this questionnaire and the DNA analysis, the team will be collecting blood samples and MRI scans from a subset of participants who chose to participate in that part of the study. The team will contact all participants every three years for up to 20 years to obtain an updated questionnaire.

There is no cost to participate in the study, and participants can reside anywhere in the United States because no travel is required to enroll in the study. Some travel may be required for the optional MRI portion of the study at the NIH (Bethesda, MD) and the participant will be reimbursed for travel cost.

All participants are assigned a unique study identification number to ensure complete confidentiality.

Using this information, the investigators plan to pinpoint specific genetic, environmental, and immunologic factors that may increase a person’s risk of developing MS. These findings may allow for earlier intervention to slow down MS or help to develop strategies for preventing the disease.

Contact: For more information about this study, please contact the research coordinator:
Alina von Korff
Phone: (617) 264-5980

Thursday, November 21, 2013

It’s more important than ever to be aware of the warning signs of multiple sclerosis, a chronic and often disabling autoimmune disease. While more than 400,000 people in the United States and 2.1 million people worldwide have MS, someone gets newly diagnosed every hour, according to the National MS Society.

Do you know what symptoms to watch for? According to Tanuja Chitnis, MD, assistant professor of neurology and director of the Partners Pediatric MS Center at Massachusetts General Hospital for Children, early symptoms of MS can include blurred vision, loss of vision, and/or numbness or tingling that lasts for several days. Dr. Chitnis indicates that while any symptoms of multiple sclerosis — including problems with motor skills, bladder control, and coordination and balance — can manifest at any point in the course of the disease, she has noticed that blurred vision and numbness tend to be symptoms common to the initial diagnosis and earlier stages of MS.

Everyone has experienced the temporary pins-and-needles numbness that accompanies resting on your arm or leg in the wrong way, but this feeling tends to go away within a few minutes as blood flow returns to the area, Chitnis says. The key to determining whether a symptom might be due to multiple sclerosis, she says, is timing; MS symptoms develop over the course of several days, and can last for several days to a few weeks.

Vision Loss Eye issues are often the first sign of multiple sclerosis. Before he received his MS diagnosis, for example, Jeffrey Gingold noticed that his vision was beginning to rapidly decline in one eye. Gingold was 36 at the time, making such dramatic vision loss extremely unusual. He scheduled an appointment with his regular eye doctor, and remembers the ophthalmologist saying, "You either have MS or you have a brain tumor." An MRI confirmed that it was multiple sclerosis.

Balance Balance and dizziness are also common initial signs of multiple sclerosis. Rick Sommers, a fit and athletic guy, was diagnosed with MS in 1994. "I was training for a marathon and my balance was off; I felt lightheaded," he remembers. "I went to a doctor who thought it was an inner ear infection." He adds wryly, "I was misdiagnosed." In fact, his balance issues were Sommers' first symptoms of MS.

Numbness/Tingling After his initial balance difficulties, Sommers began to notice tingling and numbness in his right side, which motivated him to see a neurologist. The neurologist ordered an MRI (magnetic resonance imaging), and found lesions in Sommers' brain that indicated multiple sclerosis was what was causing his symptoms.

Heat Intolerance Heat intolerance is another telltale sign of multiple sclerosis. If you feel dizzy, faint, or unusually uncomfortable in warm temperatures or when engaging in body-warming activities like soaking in a hot tub, exercising, or sunbathing, it could be a sign of multiple sclerosis. Heat intolerance also tends to make other symptoms of multiple sclerosis more pronounced.

Other MS Symptoms MS symptoms are varied and numerous. In addition to those described above, common symptoms include fatigue, pain, bowel and urinary problems, sexual dysfunction, difficulty swallowing and speech problems, cognitive (thought process) issues, and depression — among others.

Some of these symptoms are common to many disorders, and Chitnis emphasizes the importance of timing in figuring out if the symptoms could be caused by MS. If you are experiencing any of the symptoms above, for a period of more than 24 hours, there is a chance that multiple sclerosis is the cause.

Of course, any symptom that interferes with your job performance, daily functioning, or quality of life is worth discussing with your doctor, whether or not you suspect it might be related to multiple sclerosis. For many diseases, the earlier they are caught, the more effective treatment will be. Multiple sclerosis is no exception. There are now treatments available that can effectively slow disease progression, and initiating them as early as possible is generally the best course you can take.

Nevertheless, Injectables Remain First-Line Mainstays Among Newly Diagnosed Patients, According to a New Report from Decision Resources

BURLINGTON, Mass., Nov. 20, 2013 -- /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, through examination of U.S. patient-level claims data, total patient share of platform injectable disease-modifying therapies (DMTs) among recently treated multiple sclerosis (MS) patients declined over four quarters of data collection ending June 30, 2013, with a steeper drop observed in Q2 2013, coinciding with the launch of Biogen Idec's Tecfidera. Quarterly analysis shows that injectable DMTs, namely the interferon betas and Teva's Copaxone, captured a combined 70 percent patient share among recently treated patients in Q2 2013 compared with 80 percent one year earlier. Meanwhile, during the drug's first three months on the market, Tecfidera captured a sizable patient share in this population, approaching the level of Novartis's first-to-market oral DMT Gilenya in this same quarter. These data likely reflect both pent up patient demand for Tecfidera and prescribers' positive opinions of the product's clinical profile compared with other DMTs.

However, the Treatment Algorithms in Multiple Sclerosis report also finds that platform injectables continued to capture a commanding 84 percent of first-line patient share among MS DMTs. Copaxone and Biogen Idec's Avonex were most often prescribed among newly diagnosed MS patients, together capturing over 60 percent of first-line patient share in this population, likely owing to their established advantages in tolerability and delivery, respectively. Thanks to physician comfort and a positive long-term safety record, injectable DMTs maintained a dominant first-line position despite the availability of newer oral alternatives—Gilenya, Tecfidera and Genzyme's Aubagio—which combined to capture only just 6 percent of first-line patient share, driven mostly by Gilenya.

"U.S. claims data confirm that time-tested injectables remain a core component of MS treatment, overall and in treatment-naive patients, likely due in part to neurologists' conservative adoption of new agents," said Decision Resources Senior Director Jonathan W. Searles. "That said, with oral DMTs capturing nearly 18 percent total patient share in the second quarter among patients in our sample who were recently treated, and with the use of Tecfidera surging, we anticipate continued steady losses among current mainstays over the near-term."

The 29th Congress of the European Committee for the Treatment and Research in MS (ECTRIMS) was held in Copenhagen, Denmark from October 2-4, 2013. There were over 1,000 formal presentations..

There were a number of presentations relating to environmental factors that appear to influence MS. Smoking not only increases risk for developing MS, but there is a dose response curve.

The longer the duration of smoking, and the greater the intensity of smoking (packs per day), the higher the risk for MS. This is regardless of age at exposure, so this increased risk is present in young and middle aged smokers.

Increased salt intake in the diet of MS patients is connected with increased attack rate, and increased rate of new brain MRI lesions.

Teenage obesity and alcohol use (from the ages of 15 to 19), and developing clinical mononucleosis, resulted in an earlier age of onset of MS.

Other presentations focused on first attack MS patients with a clinically isolated syndrome. Low vitamin D levels predicted these patients would have greater clinical and MRI disease activity. Abnormal spinal fluid, and more than 9 brain MRI lesions, were also associated with increased future disease activity.

Hormonal states such as pregnancy have a profound impact on MS, but very little is known about what happens at menopause. A study of MS menopausal patients found that 48% reported worsening of MS symptoms (depression, fatigue, bladder, sexual dysfunction, cognitive issues).

In a study that used MRI to evaluate MS patients with depression or fatigue, they showed more signs of microscopic injury to their brain tissue than MS patients without these symptoms, implicating injury to specific brain pathways. This would support trying to minimize brain injury to decrease these major MS symptoms.

There is increasing evidence that physical exercises can change the brain. MS patients who went through balance training with a Wii board showed both clinical improvement (better balance), and brain MRI changes on diffusion tensor imaging, consistent with the exercise program causing microscopic changes.

Newer MRI techniques are being developed to evaluate the brain in MS. Lesions within the cortex can be identified and followed, and there are ways to tell if these lesions repair (remyelinate) over time. This might be a way to study potential repair therapies for MS.

In secondary progressive MS patients, autopsied brain studies indicated that diffuse inflammation was associated with active lesion damage. This raises the hope that anti-inflammatory agents, if they are able to get into the CNS, might be helpful for progressive MS.

There is an increasing focus on identifying gender based differences in MS. It is known that MS is more common in women, and men have a poorer prognosis than women. In a large MS database study, women with relapsing MS showed higher attack rates than men. Relapses fell over time. This was related more to age than duration of MS. Relapse rate may be another gender-based difference in MS.

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Tuesday, November 19, 2013

As discussed in Laura’s latest blog Lemtrada – Sanofi’s Request for a new MS Drug, the Food and Drug Administration is expected to make a decision regarding the approval of Lemtrada (alemtuzumab) for the treatment of Multiple Sclerosis later this year. An FDA advisory committee recently reviewed clinical trial results, including important safety data, to assess if Lemtrada should be available to patients with Multiple Sclerosis.

Yesterday the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee recommended approval of Lemtrada for patients with relapsing forms of MS despite serious side effects seen in clinical trials. The advisory panel specifically noted that it should be reserved for patients who have failed on other MS therapies. The panel was also asked to vote on a series or other topics concerning the medication, including effectiveness, overall safety, and a possible program that would be required to monitor the safety and side effects of Lemtrada over time.

The advisory committee discussed Lemtrada’s clinical program, including two phase 3 clinical studies in MS – CARE-MS 1 and CARE-MS 2. Highlights from these studies can be found here. The CARE-MS 1 study, which was conducted in people with MS who were treatment-naive (patients who had not yet received a disease-modifying treatment) compared Lemtrada to Rebif (interferon beta-1a). The CARE-MS 2 study was conducted in people with RRMS who had had at least one relapse while receiving either interferon beta medication or Copaxone (glatiramer acetate). In both trials Lemtrada demonstrated patients were significantly less likely to experience a relapse over the course of two years than other drug. However, reviewers questioned whether the design of the trials resulted in more favorable and potentially biased results for Lemtrada. The panel ultimately voted that the studies were insufficient to assess Lemtrada’s effectiveness, but nonetheless recommended its approval with restrictions as noted above.

It is important to note that the FDA is not required to follow the advice of its advisory committees, though it often does. The FDA is due to make a final decision on Lemtrada later this year, and the product received approval in Europe earlier this year.

Abstract

The blood-brain barrier (BBB) is a complex organization of cerebral endothelial cells (C EC), pericytes and their basal lamina, which are surrounded and supported by astrocytes and perivascular macrophages. C ollectively these cells separate and form the compartments of the cerebral vascular space and the cerebral interstitium under normal conditions. Without the BBB, the ‘interior milieu’ of the central nervous system (CNS) would be flooded by humoral neurotransmitters and formed blood elements that upset normal C NS functions and lead to vascular/neural injury. Dysregulation of the BBB and transendo thelial migration of activated leukocytes are among the earliest cerebrovascular abnormalities seen in multiple sclerosis (MS) brains and parallel the release of inflammatory cytokines/chemokines. Mechanisms for breakdown of the BBB in MS are incompletely understood, but appear to involve direct effects of these cytokines/chemokines on endothelial regulation of BBB components, as well as indirect cytokine/chemokine-dependent leukocyte mediated injury.

Unique endothelial structural features of the BBB include highly organized endothelial tight junctions, the absence of class II major histocompatibility complex, abundant mitochondria and a highly developed transport system in C EC. Exposure of endothelium to proinflammatory cytokines (IFN-g, TNF-a and IL-1b) interrupts the BBB by disorganizing cell-cell junctions, decreases the brain solute barrier, enhances leukocyte endothelial adhesion and migration as well as increases expression of class II MHC and promotes shedding of endothelial ‘microparticles’ (EMP). In this review we examine interactions between cytokines/chemokines, activated leukocytes, adhesion molecules and activated C EC in the pathogenesis of BBB failure in MS.

NeuroStar TMS Therapy is a new treatment cleared by the US Food and Drug Administration (FDA) for patients suffering from depression who have not achieved satisfactory improvement from prior antidepressant treatment. TMS stands for "transcranial magnetic stimulation."

TMS Therapy is a treatment that can be performed in a psychiatrist's office, under his or her supervision, using a medical device called the NeuroStar TMS Therapy system. NeuroStar TMS Therapy is:

Non-invasive, meaning that it does not involve surgery. It does not require any anesthesia or sedation, as the patient remains awake and alert during the treatment

Non-systemic, meaning that it is not taken by mouth and does not circulate in the blood stream throughout the body.

The typical initial treatment course consists of at least 5 treatments per week over a 4-6 week period, for an average of 20-30 total treatments. Each treatment session lasts approximately 40 minutes.

We are pleased to announce that TMS (Transcranial Magnetic Stimulation) Therapy was featured on an episode of The Dr. Oz Show. The episode, which aired on Wednesday, March 14th, featured TMS Therapy as a depression treatment option for patients who have not benefited from initial antidepressant medication. Please see Dr. Oz's page on the TMS segment to view the episode.

Disclaimer: As always, we need to inform you that we (at Stu's Views & MS News/ MS Views and News) provide this information solely to keep you informed. We do not stand behind any techniques, practices, therapies or medication. Please always consult with your physician before beginning anything new.

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MS Views and News would like to thank the more than 20 comments received after the program on November 9, 2013. Below is just a small sampling of comments. Most all the comments were of the same content, in asking when we will be back to do more programs

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Hi Stuart,

I
enjoyed the meeting very much and felt it was a very well planned event. I
thought the extra time for questions and answers was a great idea and was
quite revealing in terms of what people want to hear about. I think research,
emerging therapies, and stem cells in particular, are hot topics. I think
folks have more opportunities to hear about existing therapies through
pharmaceutical programs but not a lot of opportunities to hear about things
outside of that. It is great to be able to present balanced information
without the constraints of the pharmaceutical arena.

In
response to your e-mail about another program in March-- I spoke with Dr.
Thrower. Dr. Buckle will be joining us in March and we would like to have
some programs around that time. we can speak further about that.

Thanks
again for the wonderful opportunity –Tracy

Tracy Walker

Mr. Stuart!!!

I was so impressed with the whole
presentation! I was so overwhelmed with everything, I was beat when I got
home! I loved everything from the warm welcome (you smiled!), the speakers,
the food was excellent, and dagnabit I didn't get the tablet! LOL! I am so
happy that you all came up to Atlanta and hope you do another one for the
summer to prepare us for the humid "Hotlanta" heat. Nothing
compared to Miami, but it still gets unbearable. I have forwarded this
link to my coworker, whose husband also has MS, but very stubborn and in
denial to this moment. Although the venue was small, if you get a
larger spot, I'm sure more will come because there was a full house. I
was front in center and fortunate enough, I have access to the equipment that
was recommended in the talk because I work in the DME industry. So, I
was able to see what I would need for the future if needed. This really
put me on the map and I am now reading the wonderful book 300 Tips for MS.
ANyhoot, enough raving and rambling. Thanks again for leaving
your home and gracing us with good info. God bless you, and come again!

Danielle W.

Hello
Stuart. I wanted to let you know that I really enjoyed your recent
event. It was very organized and informative. I know it takes a
lot of work to prepare for the events and I want to thank you so much for
coming to Atlanta to share and work with everyone. I look forward to
attending your next seminar. Have a wonderful weekend my friend.
Hope to see you soon. Lisa Johnson, Lawrenceville, Ga. ;)

Dear Stuart.

Just a note of thanks for a job well done. I could tell
there was a lot of hard work done on your part. The meeting was very
informative and presented

in a format that was easy to understand. Thank you and am
looking forward to seeing

you again. -- Ruth Ann

Stuart,

I thought the program was awesome!!! I love hearing new
information regarding MS. I try to read all information I can get my
hands on. Realizing that some of it is of the untrue nature. I take
what I know and shake out the rest. The Marriott was a perfect
location. It seems that everything is geared toward Hot Atlanta.
It is sooo nice to have meetings in the burbs!! I frequent the Drug sponsored
MS meetings to get the scoop on the new and fairly new drugs and also to meet
new MSers and compare notes regarding Doctors, symptoms, reactions,
medications, future medicine rumors and such. Yes, I live a boring
life!!!!

Now, back to the Marriott, I to was surprised by the meal that
was served. Understandably, it is hard to feed a group of 167 and
everyone be happy or even half of them be happy. The salad presented was visibly
not fresh, the main course had seen its better day - the day before!!
However, the desert rocked!! Enough said!!

Thank you for allowing me to share!

Enjoy your week!! It was an awesome meeting!!

Suzanne Barbaree

Stu,

Thanks again for a great meeting!

As you know I attended many seminars in Florida which I enjoyed.
But this was the best. Thanks again for all you do and looking forward to
seeing you in Atlanta again real soon.

Brian D.

Sent from my iPhone

Congratulations for a well organized event. Philip A

Nov 16th -

Stuart, I don’t know if you remember me we met at one of your
programs. I am in the middle of watching your Atlanta program and I just had
to stop to thank you for all the knowledge you put out there for all of us
MSers. I have moved back to Erie Pa last year. I would love it if you could
put Erie Pa on your list of areas to bring your programs too! Please please
please! --- Richelle Vogel, formerly of Lehigh Acres, Fl.

SYMPTOMS of MS

In multiple sclerosis , damage to the myelin in the central nervous system (CNS), and to the nerve fibers themselves, interferes with the transmission of nerve signals between the brain and spinal cord and other parts of the body. This disruption of nerve signals produces the primary symptoms of MS, which vary depending on where the damage has occurred.

Over the course of the disease, some symptoms will come and go, while others may be more lasting.

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A web-blog (formerly known as Stu's Views and MS News), now published by MS Views and News, a patient advocacy organization. The information on this blog helps to Empower those affected by Multiple Sclerosis globally, with education, information, news and community resources.

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Disclaimer:

"Stu's Views & MS News" / 'MS Views and News' DOES NOT endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly

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MS Views and News is a 501c3 Not-for-Profit organization that provides IMPACTFUL information to the MS (Multiple Sclerosis) community. To learn of the educational programs we provide live and virtually, opt-in with us from here: www.register.msviewsandnews.org
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